MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION

Catalog Number 8065753057

Device Problem Suction Problem (2170)

Patient Problems Corneal Edema (1791); Visual Disturbances (2140)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that footswitch no longer worked and displayed error code during cortex step and ophthalmic operating console had irrigation/aspiration issues, so surgeon had to do manually during cataract surgery and put a suture on the cornea (eye unknown) of the patient.The surgery was completed on the same day with a delay of one hour.The patient also experienced corneal edema and suture associated astigmatism.The current condition of the patient was improving from the reported events.

• Brand Name: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18948220
• MDR Text Key: 338187471
• Report Number: 2028159-2024-00451
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: 00380657530571
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753057
• Device Lot Number: 14UFFF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM, FOOTSWITCH.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female